The Effect of Pink Noise and the Quiet Night Intervention on Sleep Parameters in Intensive Care Unit Patients: A Single-Center Randomized Controlled Trial (NM-ICU (Noise)

April 17, 2026 updated by: Saadet Can Çiçek, Abant Izzet Baysal University

The Effect of Pink-Brown Noise and the Quiet Time Intervention on Sleep Parameters in Intensive Care Unit Patients: A Single-Center, Randomized Controlled Trial

Sleep disruption is common in adult intensive care unit (ICU) patients and is often worsened by environmental noise and nighttime care activities. Poor sleep may negatively affect recovery and well-being.

This single-center, three-arm randomized controlled trial will evaluate the short-term effects of two non-pharmacological interventions-(1) pink-brown noise masking and (2) a quiet time intervention-on objective sleep parameters in adult ICU patients, compared with standard care.

Sleep outcomes will be measured using actigraphy-based wearable monitoring, including total sleep time, sleep efficiency, sleep onset latency, wake after sleep onset, and number of awakenings. Results are expected to support evidence-based nursing approaches to improve sleep in ICU patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is designed as a single-center, three-arm, parallel-group randomized controlled clinical trial to evaluate the short-term effects of environmental acoustic masking and a quiet night intervention on objective sleep parameters in adult intensive care unit (ICU) patients.

Sleep disturbance is highly prevalent among critically ill patients due to environmental factors such as excessive noise, continuous light exposure, frequent nursing interventions, alarm sounds, mechanical ventilation, pain, anxiety, and disease-related physiological stress. These factors lead to fragmented and superficial sleep, disruption of the sleep-wake cycle, and are associated with adverse clinical outcomes including delirium, immune dysfunction, hemodynamic instability, prolonged ICU stay, and increased morbidity.

The study includes three groups:

  1. an acoustic masking intervention group,
  2. a quiet night intervention group, and
  3. a standard care control group.

The acoustic masking group will receive low-frequency, nature-based sound exposure prior to sleep onset, followed by earplug use throughout the night. The quiet night group will receive environmental noise and light reduction measures supported by earplugs and an eye mask. The control group will receive standard ICU care without additional sleep-promoting interventions.

Objective sleep parameters will be measured using wrist-worn actigraphy over a single night (23:00-06:00). Primary sleep outcomes include total sleep time, sleep efficiency, sleep onset latency, wake after sleep onset, and number of nocturnal awakenings. Actigraphy is selected as a feasible, non-invasive, and validated method for sleep assessment in critically ill populations.

Prior to the main trial, a pilot phase will be conducted to assess the feasibility of the study procedures, the applicability of the interventions, the functionality of data collection methods, and the variability of outcome measures required for sample size estimation. The pilot phase will include all three study arms and will follow the same methodology, eligibility criteria, intervention protocols, and outcome assessments as the main trial. Participants enrolled in the pilot phase will constitute an independent sample and will not be included in the final analysis of the main trial.

Data obtained from the pilot phase will be used solely for methodological refinement and sample size calculation. Findings from the pilot phase may be disseminated separately.

The study aims to generate evidence for low-cost, non-invasive, nurse-led environmental interventions that can be integrated into routine ICU care to improve sleep quality in critically ill patients.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Inclusion Criteria:
  • Adults aged 18 years and older
  • Patients admitted to the adult intensive care unit
  • Expected ICU stay of at least one night
  • Ability to tolerate non-invasive sleep-related interventions (earplugs, eye mask, or acoustic masking)
  • Informed consent obtained from the patient or legally authorized representative

Exclusion Criteria:

Exclusion Criteria:

  • Severe hearing impairment preventing use of acoustic interventions
  • Severe cognitive impairment or coma preventing sleep assessment
  • Use of continuous deep sedation
  • Diagnosed sleep disorders requiring pharmacological treatment
  • Skin conditions preventing use of wrist-worn actigraphy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acoustic Noise Masking Group
Patients receiving environmental acoustic noise masking before and during nighttime sleep.
Behavioral: Acoustic Noise Masking Intervention
Environmental acoustic noise masking applied before and during nighttime sleep to reduce ambient ICU noise and support sleep continuity.
Active Comparator: Quiet Night Intervention Group
Patients receiving a quiet night protocol including environmental noise and light reduction supported by earplugs and eye mask.
Behavioral: Quiet Night Intervention
A quiet night protocol including environmental noise and light reduction supported by earplugs and an eye mask.
No Intervention: Standard Care Control Group
Patients receiving routine intensive care without additional sleep-promoting interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Efficiency
Time Frame: Single night (23:00-06:00)
Sleep efficiency will be measured using a single wrist-worn actigraphy device (smartwatch) during nighttime sleep (23:00-06:00).
Single night (23:00-06:00)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Sleep Time
Time Frame: Single night (23:00-06:00)
Total sleep time will be measured using the same single wrist-worn actigraphy device (smartwatch) during nighttime sleep.
Single night (23:00-06:00)
Sleep Onset Latency
Time Frame: Single night (23:00-06:00)
Sleep onset latency will be calculated as the time from lights-off to sleep onset using the same single wrist-worn actigraphy device (smartwatch).
Single night (23:00-06:00)
Wake After Sleep Onset
Time Frame: Single night (23:00-06:00)
Wake after sleep onset will be measured as the total duration of wakefulness after sleep onset using the same single wrist-worn actigraphy device (smartwatch).
Single night (23:00-06:00)
Number of Nocturnal Awakenings
Time Frame: Single night (23:00-06:00)
The number of nocturnal awakenings will be measured using the same single wrist-worn actigraphy device (smartwatch) during nighttime sleep.
Single night (23:00-06:00)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abant Izzet Baysal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIBU-SBF-NSS-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared publicly. De-identified data may be made available upon reasonable request to the corresponding investigator, subject to ethical approval and institutional regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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